Repercussions of Clinical Research Fraud and Misconduct

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Michael L. Smith, J.D., R.R.T., Board Certified by The Florida Bar in Health Law

Medical and clinical researchers, whether in an academic community or in a practice setting, spend years on clinical trials and investigations in hopes of contributing to their respective fields. Many of these researchers, however, find themselves defending their reputation after being accused of research fraud or research misconduct.

The Number of Complaints is Steadily Increasing.

Although accusations of research fraud and misconduct have been present for decades, the number of complaints is on the rise, according to the FDA. In many cases, the researcher accused of such misconduct may actually be the victim of one or more unscrupulous individuals who make the complaint for his or her own ulterior motives. Some researchers may be targeted by an academic institution or the government. Other cases may involve a "whistle blower" who may just have misunderstood the situation.

Common Accusations Researchers Face.

The most common accusations against researchers include: manipulating or concocting research data, failing to disclose financial interest or not properly disclosing conflict of interest, plagiarizing, failing to present data that contradicts one’s own previous research, overlooking the use of flawed data, and circumventing certain minor aspects of human-subject requirements. Researchers also face an enormous amount of pressure from funding sources. That influence on a researcher can lead to these accusations: changing the design, methodology or results of a study to meet a funding source’s expectations, ignoring details or cutting corners to meet a deadline, fabricating, falsifying or mishandling of data to gain some form of reward or benefit.

Accusations can Cause Serious Consequences.

An accusation, even if later proven to be unfounded, may unfairly tarnish the personal and professional reputation of the researcher, cause the researcher to lose grants, bonuses and promotions, his or her employment may be terminated, or may even face criminal prosecution for fraud, theft or other applicable crimes.

One of the most notorious recent cases of research misconduct involved a stem cell researcher in South Korea who claimed to have cloned human embryonic stem cells. However, the researcher was later accused of fabricating crucial data and charged with fraud and embezzlement. The fraud charges were eventually cleared, but not before the researcher's reputation was destroyed.

From 1992 to 2002 a former research professor in Vermont falsified and fabricated data in numerous federal grant applications and academic articles. He used two million dollars in government grants – taxpayer money - for studies to perpetrate his fraud. He pled guilty to falsifying 17 grant applications to the National Institutes of Health (NIH) and fabricating data in 10 of his papers. He was ordered to serve one year and a day in federal prison, permanently barred from ever receiving more federal research grants, and ordered to write letters of retraction and correction to a number of scientific journals.

A prominent Massachusetts anesthesiologist admitted to fabricating 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked. This data used in the studies was published in several anesthesiology journals between 1996 and 2008. This doctor was sentenced to six months in prison, followed by three years of supervised release. He was ordered to pay a $5,000 fine, forfeit $50,000 to the government and make $360,000 in restitution to pharmaceutical companies. The plea deal effectively ended his career as a physician.

The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians and clinicians who are the subject of clinical research fraud and misconduct. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers, investigators and "whistle blowers" who report such matters including those who become the victim or reprisals and retaliation by the person against whom the report is made.Don't wait. Obtain the advice and counsel of experienced attorneys who are familiar with such matters and can assist you before it is too late.

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Michael L. Smith, J.D., R.R.T., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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